Insmed Incorporated (Nasdaq: INSM), announced the FDA has placed a clinical hold on its Phase 3 clinical trials for ARIKACE in Cystic Fibrosis (CF) patients with Pseudomonas lung infections and patients with non-tuberculous mycobacterial (NTM) lung disease. It has been informed by the FDA that this decision was based on an initial review of the interim results of a long-term rat inhalation carcinogenicity study, recently reported to the agency by Insmed, with ARIKACE. In this study, rats received daily doses of ARIKACE by inhalation for up to two years. FDA has requested additional information on ARIKACE and data from the rat study. Insmed anticipates being able to supply the currently requested information and data within the next 30 days.
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced a PDUFA date of March 26, 2012 for LEVADEX, an orally inhaled migraine drug for the potential acute treatment of migraine in adults.
IntelGenx Corp. (OTCBB:IGXT) announced that Pillar5 Pharma Inc successfully passed a pre-approval inspection by the FDA for its lead product, CPI-300, which has a PDUFA date of November 13, 2011.
Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) provided an update saying that its partner AstraZeneca AB recently reported that data from their Phase 3 clinical development program (OSKIRA) to investigate fostamatinib as a treatment for rheumatoid arthritis, is expected in 2H 2012 and expects to remain on track to meet the planned US and European new drug application (NDA) filing dates in 2013. They also announced that in 1Q 2011 they had commenced a Phase 2b clinical trial (OSKIRA 4) that explores fostamatinib as a monotherapy in rheumatoid arthritis. RIGL also said that its Phase 2 clinical trial for R343 in asthma is expected to commence in 1H 2012.
ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) said that it expects PACE pivotal trial of ponatinib closing and interim data at year-end. The PACE trial involves patients with chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia. It also plans, through its partner Merck, to shortly file its NDA for ridaforolimus in patients with metastatic sarcomas.